Action Points

Note that this study of a novel TAVR device was notable not only for its high success rate, but low rate of pacemaker implantation - often the "Achilles's heel" of TAVR devices.

Further replication and head-to-head comparison may be necessary to confirm the new device's better performance characteristics.

The Centera transcatheter self-expanding nitinol valve may take transcatheter aortic valve replacement (TAVR) to the next level for paravalvular leak and permanent pacemaker implantation rates, according to the pivotal safety study.

Mortality was 1% at 30 days after implantation of the low-profile, 14-French-compatible valve delivered by a motorized delivery system that allows it to be repositioned, Herman Reichenspurner, MD, PhD, of Germany's University Heart Center Hamburg, and colleagues reported in the Dec. 26 issue of the Journal of the American College of Cardiology. The rate of disabling stroke was 2.5%.

Hemodynamic results were "excellent," according to an accompanying editorial. Effective orifice areas widened from 0.71 to 1.88 cm2, and the mean aortic transvalvular gradient fell from 40.5 to 7.2 mm Hg at 30 days (both P<0.001).

Notably, just 0.6% of patients had moderate-or-worse paravalvular aortic regurgitation and 4.5% got new permanent pacemakers.

"The results show adequate early clinical safety and performance outcomes in this high-surgical-risk patient cohort," Reichenspurner's group said.

However, they clarified that the decision of whether to place a pacemaker was up to the operators' discretion, acknowledging that just seven out of 14 patients with grade III atrioventricular block got a pacemaker (the other seven conduction abnormalities were adjudicated as transient events). "Therefore, the low permanent pacemaker rate should be interpreted with care and has to be confirmed in larger patient series," the authors said.

For now, "the Centera valve seems to have an optimal equilibrium between the incidence of paravalvular leak and conduction disturbances requiring permanent pacemaker implantation," according to Luis Nombela-Franco, MD, PhD, of Hospital Clínico San Carlos in Madrid, who noted in an accompanying editorial comment the 11.6% rate of new-onset left bundle branch block.

Even the "real" 5.3% permanent pacemaker rate (10 implanted among patients without prior pacemakers in the as-treated population) associated with the Centera makes it "the lowest compared with any other transcatheter heart valve," he added.

Another self-expanding valve, the Lotus, was notably flagged after almost one-third of patients had to get pacemakers in the RESPOND post-market study. That figure has since dropped to 11.8% after a device redesign. The newer-iteration Lotus Edge is still under voluntary recall in Europe.

The present study tested the Centera in 203 patients in Europe, Australia, and New Zealand with severe symptomatic aortic stenosis who were at high surgical risk. The average age of the study population was 82.7 years, and 67.5% were women.

More than two-thirds were in New York Heart Association (NYHA) functional class III/IV at baseline. After TAVR with Centera, NYHA functional class dropped down to class I/II for 93.0% of the group.

Transfemoral TAVR was successful 97.5% of the time. There was a 3.5% rate of cases requiring heart valve recapture and repositioning.

"Although TAVR has demonstrated similar or even lower rates of mortality, stroke, major bleeding, acute kidney injury, and new-onset atrial fibrillation compared to surgery, paravalvular leak and permanent pacemaker implantation have been considered the Achilles' heel of TAVR," wrote Nombela-Franco. "Some of the key mechanistic factors in these two complications may be inversely related, and improving one factor may jeopardize the other. Devices that further increase the strength to seal the paravalvular space usually result in a higher likelihood of the device mechanically interacting with the conduction system in the [left ventricular outflow tract]."

That's what makes the findings by Reichenspurner's group "of paramount value," according to the editorialist.

"This study demonstrates that the goal of a permanent pacemaker implantation rate of ~5% is achievable with transcatheter heart valves and at least similar to the permanent pacemaker implantation rates of previous surgical series," he suggested. "If we are able to reduce significant paravalvular leak and permanent pacemaker implantation rates to 1% and 5%, respectively, this valve would represent a major step forward in the TAVR horizon with clinical improvement for our patients."

Nevertheless, Nombela-Franco noted that the baseline electrocardiographic data being missing in this paper limits the understanding of the patients' underlying risk.

The trial was funded by Edwards Lifesciences.

Reichenspurner disclosed receiving speaker support and travel honoraria from Edwards Lifesciences; and has served as a consultant to HeartWare/Medtronic.

Nombela-Franco has served as a proctor for Abbott and has received speaker honoraria from Edwards Lifesciences.

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